Prevention and Treatment of Hemodialysis Vascular Access Malfunction

End-Stage Renal Disease Clinical Trial

Official title:

Prevention and Treatment of Hemodialysis Vascular Access Malfunction

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00179192
• Other study ID #: 9318
• Status: Withdrawn
• Phase: Phase 2
• First received: September 13, 2005
• Last updated: May 21, 2015
• Start date: May 1998
• Est. completion date: October 2006

Study information

• Verified date: May 2015
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Vascular access is considered the Achilles heel of the dialysis patient. It constitutes the largest single cause of morbidity in the chronic hemodialysis population, accounting for over 25% of hospitalizations at an estimated cost in the US of at least one billion dollars annually. Currently, complication free survival of vascular access ranges between 30-50% a year and multiple investigative efforts in this area have been initiated and are directed at prolonging the functional life of vascular accesses.

It is not well established whether intervention prior to overt malfunction or thrombosis of the vascular access could reduce these complications and thereby improve the functional longevity of the access. Moreover, once accesses at potential risk are identified, it is not well established which method of intervention, Surgery vs. Angioplasty vs. Expectant Management, is superior in terms of clinical and financial outcome. The proposed study aims to determine whether early intervention of a vascular access determined to be at risk of malfunction and thrombosis improves the long term outcome and, specifically, which means of intervention is preferred.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2006
• Est. primary completion date: October 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

1. Subjects with End Stage Renal Disease on chronic maintenance hemodialysis 3 times per week

2. Have an arteriovenous (polytetrafluoroethylene) graft as vascular access

3. Have a venous stenosis between 30% and 70% as determined by angiogram

Exclusion Criteria:

1. Native arteriovenous fistula

2. Known previous vascular accesses complications, such as central vein stenosis, and multiple access surgeries >4

3. Unwilling to participate

4. Allergy to iodine

5. Absolute contraindication for surgery (e.g. medical condition precludes anesthesia and surgery)

6. Known arterial limb stenosis or long vessel length venous stenosis which are unamenable to surgical or angioplasty techniques, respectively, and therefore prohibit randomization

7. Known hypercoagulable state

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• End-Stage Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic

Intervention

Procedure:
• angioplasty
angioplasty performed at the time of the angiogram; approach and technique to be determined by the interventional radiologist
• surgery
surgical revision of patient's PTFE in a timely fashion not to exceed 72-96 hours after the angiogram; method of revision to be determined by the surgeon performing the procedure

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To test the hypothesis that early intervention of a vascular access determined to be at increased risk of malfunction and thrombosis improves the long-term access outcome versus standard of care.		2 years	No
Secondary	To determine which means of early intervention, surgery versus angioplasty, is medically and financially advantageous.		2 years	No